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Generally, it includes two test requirements, say, Non-clinical tests and Clinical test;
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For non-clinical test, the sphygmoomanometer shall be verified acc. to below standards5 P" t7 F* I8 n' u6 v* U3 M
1 .Electrical safety: IEC 60601-1 or UL 60601-1
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3. FCC : FCC part 15. B3 d0 `1 O }
4. safety and performance characteristics: ANSI/AAMI SP10
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3 O/ i& g+ L7 r; i8 yFor Clinical test, $ {- _* b [. p) G/ R/ }8 m" f
In compliance with the essential requirements of ANSI/AAMI SP10.
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6 a6 e6 f1 \( R3 k" K* Q1 zHope it helps a bit! |
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